ELISA assays are quick, convenient, and simple to perform. ELISA assay method is one of the most employed assays in drug discovery and development. Because of its versatility in detecting different analytes in biological samples and its ability to provide qualitative and quantitative data, ELISA assays have emerged as a powerful technique for the drug development process. However, with a range of ELISA testing service available, it can be difficult for sponsors to choose the right fit. Hence, the current article highlights points sponsors must consider while selecting ELISA assay development services.
Assay format
Depending on the research goals, sponsors can choose from different ELISA formats. There are four major types of ELISA formats; direct, indirect, sandwich, and competitive ELISAs. Direct ELISAs are best for rapid detection of an antigen. Indirect ELISAs work best for flexible and sensitive assays. Sandwich ELISAs provide higher sensitivity, flexibility, and specificity for highly complex samples. Besides, competitive ELISAs are ideal for smaller molecules that are difficult to capture by employing two different antibodies. Hence, an ideal ELISA testing service must understand the research needs and perform each assay type.
Sample species and type
Study species such as humans, rats, and mice have readily available ELISA kits. However, sponsors have very limited assay options for more complex samples such as canine, monkey, or porcine. Hence, sponsors must choose an ELISA assay development service that can develop and validate an ELISA assay for your sample species.
Besides, always ensure whether the ELISA testing service has experience validating the sample type of your study. There is a wide range of sample matrices, including serum, plasma, tissue, cell lysate, and cell culture supernates. Hence, always confirm the experience of a partner laboratory in the sample of your choice.
Specificity
Cross-reactivity is often a significant issue with ELISA assay methods. After performing an ELISA assay, a strong generated signal is most often due to a false-positive result. The antibodies attach to themselves or other molecules and produce false-positive results. Besides, interference can further inhibit antibodies from binding to the target analyte. Hence, choose an ELISA testing service to optimize the assay with minimal to no interference and cross-reactivity.
Sensitivity
ELISA assay development services must be experienced enough to achieve high assay sensitivity. Often sponsors have a general idea about the target analyte concentration. In cases where the concentration is unknown, the partner laboratory must be able to choose a broad dynamic range. On the other hand, ELISA assays must be highly sensitive for analytes at lower levels. Moreover, testing services must develop assays with detection capabilities at picogram levels.
Rigorous ELISA assay validation
A validated method is a key to reliable results. A developed assay must deliver consistent results. Hence, testing services must be able to validate the developed ELISA assay. A thoroughly validated ELISA assay will not only perform consistently but will also produce results that are comparable over time. An ideal ELISA testing service will have tons of experience developing and validating ELISA assays. Besides, they should be comfortable sharing the validation data for evaluation.
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